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Ultra-Hypofractionated Partial Breast Irradiation / Breast Cancer Early Stage Breast Cancer (stage 1 3) / Ultra-Hypofractionated Whole Breast Irradiation · Interventional Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned phase II randomized trial registration with no results posted. The study will compare ultra-hypofractionated partial breast irradiation versus whole breast irradiation in 100 women with early-stage breast cancer, using acute skin toxicity and patient-reported outcomes at 3 months as the primary endpoint. No outcome data are available in this registry record.
Interventional, Randomized, Parallel, Single masking, Treatment purpose. Breast Cancer Early Stage Breast Cancer (Stage 1-3); Female; age from 45 Years. Intervention: Partial Breast Irradiation (PBI). Compared with: Whole Breast Irradiation (WBI) — Active Comparator. n = 100. 3 sites: Pakistan, Saudi Arabia, United Arab Emirates.
This is a planned phase II randomized trial registration with no results posted. The study will compare ultra-hypofractionated partial breast irradiation versus whole breast irradiation in 100 women with early-stage breast cancer, using acute skin toxicity and patient-reported outcomes at 3 months as the primary endpoint. No outcome data are available in this registry record.
No results are posted in this registry record; efficacy, safety, and toxicity data are not yet available.
Clinicians should monitor this trial as it addresses whether partial breast irradiation can reduce toxicity while maintaining efficacy compared to whole breast irradiation. Results from this phase II study may inform the design of a larger definitive trial but should not guide practice until outcomes are published.
This is a phase II RCT registration with no posted results; it describes a planned study comparing partial versus whole breast irradiation in early-stage breast cancer, addressing an important clinical question but presenting no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should monitor this trial as it addresses whether partial breast irradiation can reduce toxicity while maintaining efficacy compared to whole breast irradiation. Results from this phase II study may inform the design of a larger definitive trial but should not guide practice until outcomes are published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07811635). This is a study registration, not published results. Lead sponsor: Jinnah Postgraduate Medical Centre. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Interventions: RADIATION: Ultra-Hypofractionated Partial Breast Irradiation; RADIATION: Ultra-Hypofractionated Whole Breast Irradiation. Primary outcome measures: Number of Participants With Acute Treatment-Related Adverse Events by CTCAE Grade and Acute Treatment-Related Symptoms Reported Using PRO-CTCAE , 3 months after completion of radiotherapy. Brief summary: Breast-conserving surgery followed by radiotherapy is a standard treatment for women with early-stage breast cancer. Whole breast irradiation (WBI) is the current standard approach, but partial breast irradiation (PBI), which treats only the area surrounding the original tumor, may reduce radiation exposure to healthy tissues while maintaining similar treatment effectiveness. The PRISM Trial is a prospective, multicenter, phase II randomized controlled trial that will compare ultra-hypofractionated PBI and WBI using the same radiation schedule of 26 Gy delivered in five fractions with intensity-modulated radiotherapy (IMRT). One hundred eligible women with early-stage breast cancer will be randomly assigned to receive either PBI or WBI after breast-conserving surgery. The primary objective is to compare acute treatment-related skin toxicity between the two treatment approaches using both clinician-reported Common Terminology Criteria for Adverse Events (CTCAE v6.0) and patient-reported outcomes (PRO-CTCAE). Secondary objectives include evaluation of early and late toxicity, dosimetric parameters, normal tissue complication probability (NTCP), and the relationship between radiation dose distribution and clinical toxicity over 12 months of follow-up.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.